Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)

Oxygenation During One Lung Ventilation Clinical Trial

— FLOLAN  

Official title:

A Pilot Study of the Effects of Nebulized Epoprostenol (Flolan) and Systemic Phenylephrine on Arterial Oxygenation During One Lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748265
• Other study ID #: 14-7520
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2018
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing esophagectomy via video assisted thoracoscopy surgery or open thoracotomy.

• Patients greater than eighteen years old that have the capacity to provide consent.

• Patients who weigh 89kg or less.

• Patients with a preoperative platelet count > 100,000mm3

Exclusion Criteria:

• Contraindication or allergy to any of the study drugs e.g. epoprostenol, phenylephrine, sevoflurane or propofol.

• Spirometry: Force expiratory Volume (FEV1) less than 80% predicted for age. Patients with spirometry indicative of obstructive lung disease are less likely to develop hypoxemia during OLV compared to patients with normal spirometry . These patients are likely to have a smaller treatment effect if any.

• A history of a bleeding diathesis.

• Use of a platelet inhibitor within the last seven days e.g. Aspirin, clopidogrel

Related Conditions & MeSH terms

• Oxygenation During One Lung Ventilation

Intervention

Drug:
• Inhaled Epoprostenol and phenylephrine
After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously
• Sevoflurane
Volatile maintenance anesthesia
• Propofol
Intravenous maintenance anesthesia

Locations

Country	Name	City	State
Canada	Toronto General Hospital, 200 Elizabeth St.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary	Changes in base status in pH		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary	Differences between anesthetic technique -volatile vs. intravenous- in increase of arterial oxygen tension in mmHg, during one-lung ventilation surgery, in response to combined nebulized epoprostenol/phenylephrine treatment		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary	Changes in mean arterial blood pressure in mmHg		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary	Changes in platelet function count		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).
Secondary	Changes in acid status in pH		Changes measured during surgery, from start of treatment at 30 minutes after one-lung ventilation (T30) to end of the 30 minutes treatment (T60).